Real-world comparison of febrile neutropenia rates with same-day versus next-day administration of pegfilgrastim.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 299-299
Author(s):  
Kyle Kitchen ◽  
Michael C. Mosier
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Real World ◽  
Salt Lake ◽  
Salt Lake City ◽  
B Cell Lymphoma ◽  
Common Side Effect ◽  
Chi Square ◽  
Myelosuppressive Chemotherapy ◽  
The Difference

299 Background: Febrile neutropenia (FN) is a common side effect of myelosuppressive chemotherapy. Per guidelines, prophylactic pegfilgrastim is to be given 24-72 hours after chemotherapy in each cycle, but administering pegfilgrastim within 24 hours of chemotherapy (same day) is commonly done to reduce the burden on patients (pts) and healthcare systems. The ideal timing is under debate in the supportive oncology care field, but an increasing body of knowledge supports same-day administration as an option. The objective of this study was to compare the incidence of FN after same-day vs next-day administration of pegfilgrastim in pts with cancer receiving cytotoxic chemotherapy. Methods: A real-world, retrospective study of electronic health records of pts treated at Utah Cancer Specialists (Salt Lake City, UT) between February 2018 and December 2020 was conducted. Pts included in the study had a diagnosis of breast cancer, diffuse large B-cell lymphoma, or other cancers (eg. other lymphomas, prostate cancer); received a myelosuppressive chemotherapy regimen; and were administered either same-day or next-day prophylactic pegfilgrastim. FN was physician diagnosed; differences in FN incidence with same-day vs next-day pegfilgrastim were evaluated using a Chi-square test and Wald confidence limits. Results: 297 pts were included in this analysis. Most pts (63.6%) had a diagnosis of breast cancer, 23.6% had lymphoma, and 12.8% had other cancers. Pts received a broad range of chemotherapy regimens, with dose-dense doxorubicin and cyclophosphamide being the most common (43.4%). In cycle 1, pegfilgrastim administration timing was balanced between same-day (39.7% [118/297]) and next-day (60.3% [179/297]). The pegfilgrastim administration day changed in subsequent cycles in 27 pts (9.1%): 4 pts in the cycle 1 same-day group and 23 pts in the cycle 1 next-day group. In cycle 1, 7/117 pts (6.0%) in the same-day pegfilgrastim group and 12/180 (6.7%) pts in the next-day group experienced ≥1 episode of FN. Across all cycles, 11/118 pts (9.3%) in the same-day pegfilgrastim group and 16/179 (8.9%) pts in the next-day group experienced ≥1 episode of FN. The difference in incidence of FN between same-day vs next-day pegfilgrastim was not statistically significant in cycle 1 (0.68% [95% CI –5.0% to 6.3%]; P=.814) and across all cycles (–0.38% [95% CI –7.1% to 6.3%]; P=.910). Conclusions: The overall incidence of FN was low in this pt population receiving prophylactic pegfilgrastim, and no significant differences were detected between same-day and next-day pegfilgrastim administration. These data support the same-day administration of prophylactic pegfilgrastim.

scholarly journals The Impact of Baseline Risk Factors on the Incidence of Febrile Neutropenia in Breast Cancer Patients Receiving Chemotherapy with Pegfilgrastim Prophylaxis: A Real-World Data Analysis

2021 ◽  
Vol 8 (1) ◽  
pp. 106-115
Author(s):  
Edward Li ◽  
Bridgette Kanz Schroader ◽  
David Campbell ◽  
Kim Campbell ◽  
Weijia Wang
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Febrile Neutropenia ◽  
Real World ◽  
Primary Prophylaxis ◽  
Patient Specific ◽  
Myelosuppressive Chemotherapy ◽  
Comparative Analyses ◽  
Specific Risk ◽  
The Impact

Background: There are sparse data addressing whether standard risk factors for febrile neutropenia (FN) are relevant in patients receiving myelosuppressive chemotherapy and primary prophylaxis for FN, which would have implications for variables to consider during real-world comparative analyses of FN incidence. Objective: To assess the impact of baseline patient-specific risk factors and regimen risk on the incidence of FN in patients receiving pegfilgrastim primary prophylaxis. Methods: This was a retrospective observational study in patients with breast cancer (BC) who received myelosuppressive chemotherapy and prophylactic pegfilgrastim identified January 1, 2017-May 31, 2018 from MarketScan® research databases. The outcomes were defined as incidence of FN in the first cycle and among all cycles of chemotherapy using three different definitions for FN. Logistic regression and generalized estimating equations models were used to compare outcomes among patients with and without patient-specific risk factors and among those receiving regimens categorized as high-, intermediate-, or other-risk for FN (low-risk or undefinable by clinical practice guidelines). Results: A total of 4460 patients were identified. In the first cycle of therapy, patients receiving intermediate-risk regimens were at up to 2 times higher risk for FN across all definitions than those receiving high-risk regimens (P<0.01). The odds ratio for main FN among patients with ≥4 versus 0 risk factors was 15.8 (95% confidence interval [CI]: 1.5, 169.4; P<0.01). Patients with ≥3 FN risk factors had significantly greater risks for FN across all cycles of treatment than those with no risk factors; this was true for all FN definitions. Discussion: The choice of FN definition significantly changed the impact of risk factors on the FN outcomes in our study, demonstrating the importance of evaluating all proxies for true FN events in a database study. This is particularly important during real-world study planning where potential missteps may lead to bias or confounding effects that render a study meaningless. Conclusions: In patients with BC receiving chemotherapy with pegfilgrastim prophylaxis, patient-specific risk factors and regimen risk levels are determinants of FN risk. In real-world studies evaluating FN incidence, it is imperative to consider and control for these risk factors when conducting comparative analyses.

Real-world Indian scenario of CDK4/6 inhibitors (palbociclib and ribociclib) with endocrine therapy in upfront hormone positive metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13028-e13028
Author(s):  
Ajay Gogia ◽  
Shalabh Arora ◽  
Priyanshu Choudhary ◽  
Rakesh Kumar ◽  
Sanjay Thulkar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Real World ◽  
De Novo ◽  
Metastatic Breast ◽  
Common Side Effect ◽  
Drug Discontinuation ◽  
Grade 3 ◽  
Visceral Disease

e13028 Background: CDK4/6 inhibitors (CDKi), in combination with endocrine therapy (ET), has become the standard of care in the treatment of hormone positive (HR+)/ HER2 neu negative metastatic breast cancer (MBC) patients. We evaluated clinical outcomes and toxicity in MBC patients, who have received ET with two CDKi, namely palbociclib and ribociclib. Methods: This is an ambispective, single institutional analysis of de-novo HR+ MBC patients treated with CDKi (palbociclib 125 mg and ribociclib 600 mg once a day for 21 days /28 days cycle) from November 2016- October 2020 at AIIMS, New Delhi, India. The primary endpoint was progression-free survival (PFS) and the secondary endpoint was response rate and toxicity. A total of 157 female patients were recruited in this study however the response and toxicity data were available in 120 cases. All premenopausal women received ovarian suppression or ovarian ablation. Results: A total of 120 patients were included in this study with a median age of 57 years (35-75) and 93 (77.5%) cases were postmenopausal. Twenty-three (19.1%) patients had a bone-only disease, 49 (40.9%) had bone and visceral disease and 48 (40%) had only visceral disease. In this study 91 (75.9%) patients received palbociclib and 29 (24.2%) received ribociclib. The median PFS was 18 months (4-36). Twenty four (20%) patients achieved a complete response, 69 (57.5%) patients attained partial response, 18(15%) patients had stable disease and 9 (7.5%) had disease progression. Grade 3–4 neutropenia, thrombocytopenia, and anaemia were observed in 18(15%), 8 (6.7%), and 4 (3.3%) cases respectively. None of the patients developed febrile neutropenia. Cutaneous, renal, hepatic, and gastrointestinal toxicity was observed in 1,1,3,4 cases respectively. Prolonged QTc was observed in one case. Grade 3 fatigue was observed in 7 cases. Dose interruption/delay (mean dose delay of 7 days), dose modification, and drug discontinuation were observed in 24 (20%), 12 (10%), and 10 (8.3%) of cases respectively. Conclusions: This is one of the largest real-world Indian data on CDK4/6 inhibitors on upfront HR+ MBC. Side effects are less than published literature with similar efficacy. Neutropenia was the most common side effect which was managed by brief dose interruption.

Real-world utilization and costs with biosimilar and reference filgrastim in patients with breast cancer receiving myelosuppressive chemotherapy in a community oncology setting from 2015 to 2017.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 57-57
Author(s):  
Robert M. Rifkin ◽  
Lisa Herms ◽  
Chuck Wentworth ◽  
Anupama Vasudevan ◽  
Kimberley Campbell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Initial Period ◽  
The United States ◽  
Time Frame ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Myelosuppressive Chemotherapy ◽  
Community Oncology ◽  
The Us

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.

Cost of chemotherapy-related febrile neutropenia

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6068-6068 ◽  
Author(s):  
D. Weycker ◽  
J. Malin ◽  
A. Glass ◽  
G. Oster
Keyword(s):  
Febrile Neutropenia ◽  
Source Population ◽  
Tumor Type ◽  
Type Number ◽  
Myelosuppressive Chemotherapy ◽  
Study Population ◽  
Baseline Characteristics ◽  
The Difference ◽  
Initial Hospitalization ◽  
Number Of Cycles

6068 Background: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy that typically necessitates hospitalization. While the costs of FN have been reported to be substantial, previous studies may have underestimated these costs due to failure to account for follow-on care. Methods: A retrospective cohort study was undertaken using a US healthcare claims database. The source population included adult cancer patients who received a course of chemotherapy between 2001 and 2003. For each such patient, each unique cycle of chemotherapy was identified, and patients who developed FN within these cycles were further identified based on hospitalization for neutropenia, fever, and/or infection. Patients with FN in a given cycle (“cases”), starting with the first, were matched–on tumor type, number of cycles, chemotherapy characteristics, and propensity score–to those not experiencing FN in that cycle (“controls”), regardless of occurrence of FN in subsequent cycles; once matched, patients were removed from their respective pools. FN-related healthcare charges–including inpatient, outpatient, and drug treatment for neutropenia, fever, and infection–were tallied for each such pair of patients from the cycle day on which cases developed FN through the last chemotherapy cycle. Healthcare charges were used as a proxy for costs, as the latter were unavailable. Results are reported as means and 95% confidence intervals. Results: The study population consisted of 746 patients; 38% had breast cancer, 21% had lung cancer, and 11% had non-Hodgkin’s lymphoma. Cases and controls were similar in terms of baseline characteristics. FN-related charges totaled $40,928 (95%CI $28,783-$62,586) among cases versus $3,933 ($2,890-$5,119) for controls, a difference of $36,995 ($25,283-$58,776). Non-FN-related charges were similar in the two groups ($32,774 [$28,587-$36,061] vs. $32,253 [$29,248-$36,066]). Care subsequent to initial hospitalization accounted for $9,872 (or 27%) of the higher FN-related charges among cases. Conclusions: Costs of care during chemotherapy are twofold higher among patients who develop FN; follow-on care represents more than one-quarter of the difference. [Table: see text]

scholarly journals Screening and Early Diagnosis of Breast Cancer: Assessment of Knowledge and Practical Abilities of Final Year Nursing and Midwifery Students in Health Schools of Ouagadougou

2017 ◽  
Vol 2 (3) ◽  
pp. 47
Author(s):  
Nayi Zongo ◽  
Sanon/Lompo Marthe Sandrine ◽  
Bambara H. Aboubacar ◽  
Soma Chantal ◽  
Bambara Augustin Tozoula ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Diagnosis ◽  
Clinical Signs ◽  
Study Data ◽  
P Value ◽  
Screening Methods ◽  
Breast Cancers ◽  
Chi Square ◽  
Cross Sectional ◽  
The Difference

The Objective was to assess the knowledge and practical abilities of final year nursing and midwifery students in health schools of Ouagadougou relating to screening and early diagnosis of breast cancer. This is a cross-sectional, prospective and descriptive observational study conducted from 1st November 2014 to 31st January 2015. A sample of 403 students was used for this study. Data were collected using an individual questionaire and were typed on Epi data and then analyzed on SPSS software. Chi-square tests were used to compare the different proportions. The difference is considered to be significant if p value < 0.05. Three hundred and ninety nine students filled the questionnaire, i.e. a rate of non-respondents of 1%. All students were aware of the existence of breast cancer. The media (47.8%) was the main source of information. The level of knowledge of students was satisfactory with frequencies of 83.9% for risk factors; 91.6% for clinical signs; 83.4 % for screening methods and 88.1% for therapeutic terms of breast cancers. However, focus should be put on the teaching of cancerology and the supervision of students during internship, must be reinforced. These results attest that the level of students in the knowledge and practical abilities concerning screening and early diagnosis of breast cancer is satisfactory.

Treatment patterns of docetaxel and paclitaxel in patients with early-stage breast cancer in a community oncology center

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17550-e17550
Author(s):  
M. Tangirala ◽  
C. Lei ◽  
H. Joel ◽  
N. Christiansen ◽  
S. Sullivan
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Early Stage ◽  
Dose Schedule ◽  
Treatment Patterns ◽  
Stage I ◽  
Weekly Schedule ◽  
Chi Square ◽  
Community Oncology ◽  
Oncology Center

e17550 Background: Docetaxel and paclitaxel have been widely used in treating breast cancer (BC). This study aimed to describe real-world treatment patterns of two taxanes in early-stage BC. Methods: Georgia Oncology Specialist Database (GOSD) was used and contained chemotherapy, medical and pharmacy claims, and lab results for nearly 170,000 patients with various types of cancer (2003–2008). Patients with stage I-III BC receiving doxirubicin-cyclophosphamide-taxane (ACT) were identified, and their pre-taxane and on-taxane periods (from first to last dose of docetaxel/paclitaxel) were examined. Number of cycles was compared using Student's t-test. Taxane dose schedule and the use of other chemotherapy in pre- and on-taxane periods were compared using Chi-Square test. A similar analysis was replicated using Pharmetrics database (2003–2008) in BC patients on ACT regimen with prior mastectomy. Results: In GOSD, 79 docetaxel (7.9%, 58.2%, 34.2% in stage I, II, III, respectively) and 139 paclitaxel (10.8%, 64.7%, 25.5% in stage I, II, III, respectively) patients were identified. Compared with paclitaxel, docetaxel patients completed more cycles (4.9 vs. 3.9, p < 0.001), were less frequently on weekly schedule, and more frequently on every-two-week (Q2w) or every-three-week (Q3W) schedules (2.5% vs. 15.2%, 27.9% vs. 62.6%, and 41.8% vs. 0%; p < 0.001). 22.8% of docetaxel patients received AC followed by docetaxel (AC>T) and 77.22% received ACT concurrently, while 100% of paclitaxel patients were on AC>T regimen. In Pharmetrics data, compared with paclitaxel (n = 211), docetaxel patients (n = 96) completed more cycles (11.3 vs. 4.6, p < 0.001), were less frequently on weekly, while more frequently on Q2W and Q3W schedules (3.1 vs. 9.5%, 9.4% vs. 62.6%, and 59.4% vs. 4.7%; p < 0.001). While 97.6% of paclitaxel patients were on AC>T regimen, AC>T and ACT regimens were evenly split among docetaxel patients (49% vs. 51%). Conclusions: Docetaxel and paclitaxel have different treatment patterns in real-world clinical practice. The patterns in a community oncology center appear to be consistent with national data. A potential limitation of this study is that the potential selection bias may not be fully adjusted. [Table: see text]

Incidence of febrile neutropenia with use of docetaxel plus cyclophosphamide (TC) for breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12073-e12073 ◽  
Author(s):  
Kiran Patel ◽  
Brenda Diergaarde ◽  
Adam Brufsky ◽  
Rachel Catherine Jankowitz ◽  
Barry C. Lembersky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Standard Dose ◽  
Age At Diagnosis ◽  
High Rate ◽  
Hormonal Status ◽  
Breast Cancer Patients ◽  
Chi Square ◽  
Logistic Regression Models ◽  
Significant Difference

e12073 Background: Incidence of febrile neutropenia (FN) is reported as 5% in breast cancer patients receiving TC (Jones et al., JCO 2006), which would not justify the usage of prophylactic granulocyte colony stimulating factors (G-CSF). We previously showed that the incidence of FN may be as high as 23% in a small study. (N = 130, Soni et al., ASCO 2011). In the current study, we determined the incidence of FN in a larger cohort (N = 415), and evaluated the usage of G-CSF and its relation to FN, age, stage, and hormonal status. Methods: We retrospectively reviewed the electronic medical records from patients diagnosed with breast cancer who received at least one standard dose cycle of adjuvant TC between 2010-2016 at a university-based breast oncology practice. Chi-square or Fisher’s exact tests were used to assess differences between groups. Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated using multiple logistic regression models. Results: We identified in total 415 patients who received adjuvant TC. Median age at diagnosis was 58 (range: 25-86), the majority had stage I or II (N = 382; 92.1%) disease, and 315 (75.9%) were ER+, 277 (66.8%) PR+, 42 (10.1%) HER2+, 22 (5.3%) triple-positive, and 81 (19.5%) triple-negative. Prophylactic G-CSF was utilized in 247 patients (59.5%), and unknown for 43 (10.4%). Overall 39 (9.4%) patients experienced febrile neutropenia. Incidence of FN among those receiving G-CSF was 4.5% versus 17.6% among those who did not (p < 0.001). Use of G-CSF significantly lowered risk of FN, OR (95%CI): 0.20 (0.10-0.43) adjusted for age at diagnosis and stage. Use of G-CSF on incidence of FN did not differ significantly by age, stage, or hormonal status. Conclusions: Our data confirms a high rate of FN in patients receiving TC without G-CSF prophylaxis. Our institutional high rate of G-CSF use ( > 50%) reduced the incidence of FN to 4.5% and the observed significant difference in FN incidence between the non G-CSF group and G-CSF group suggests that prophylaxis may be considered when administering TC. Age, stage, and hormonal status do not seem to affect the usage of G-CSF or incidence of FN in our population.

Use of granulocyte colony stimulating factor (GCSF) in patients receiving highly myelosuppressive chemotherapy for breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21677-e21677 ◽  
Author(s):  
Emily Kornelsen ◽  
Winson Y. Cheung
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Real World ◽  
Regression Models ◽  
Population Based ◽  
Neutropenic Fever ◽  
Poor Performance Status ◽  
Breast Cancer Patients ◽  
Myelosuppressive Chemotherapy ◽  
The Real

e21677 Background:We hypothesized that GCSF use may be suboptimal in the real world despite prior research that shows prophylaxis with GCSF can reduce neutropenic fevers and hospitalizations. Our aims were to characterize patterns of GCSF use in a population-based cohort of breast cancer patients receiving highly myelosuppressive chemotherapy and to describe outcomes and predictors associated with appropriate GCSF prophylaxis. Methods:Patients diagnosed with breast cancer from 2008 to 2012, seen at any 1 of 5 comprehensive cancer centers in a Canadian province, and treated with chemotherapy that posed > 20% risk of neutropenic fever were reviewed. Associations between GCSF use and 1) patient and physician factors and 2) treatment outcomes, including rate of neutropenic fevers, were analyzed using regression models. Results:We included 805 women: median age was 52 (IQR 44 to 61) years, 40% reported smoking, 52% used alcohol regularly, 64% were ECOG 0, and 24% had private health insurance. In this cohort, 330 (41%) patients were given GCSF. Among those treated with GCSF, 132 (40%) and 198 (60%) individuals received GCSF as primary and secondary prophylaxis, respectively. Overall, neutropenia was noted in 467 (58%) cases while neutropenic fever was experienced by 161 (20%) patients. When compared to those who did not use GCSF, patients who used GCSF experienced a lower rate of neutropenia (14% vs. 61%, p < 0.01) and a decreased incidence of neutropenic fever (8% vs. 23%, p < 0.01). In regression models, patients lacking extended medical coverage (32% vs. 49%, p = 0.02), poor performance status (30% vs. 55%, p = 0.03), and those who were evaluated at non-teaching institutions (25% vs. 69% p < 0.01) were less likely to receive GCSF. Patients seen at non-teaching institutions were also given primary GCSF prophylaxis less frequently (16% vs 59%, p < 0.01) than those at teaching centers. Conclusions:GCSF prophylaxis was associated with improved neutropenia-related outcomes in the real world. Despite evidence-based recommendations, use of GCSF remains suboptimal in this population-based cohort of breast cancer patients receiving highly myelosuppressive chemotherapy.

First and Subsequent Cycle Use of Pegfilgrastim Prevents Febrile Neutropenia in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study

2005 ◽  
Vol 23 (6) ◽  
pp. 1178-1184 ◽  
Author(s):  
Charles L. Vogel ◽  
Marek Z. Wojtukiewicz ◽  
Robert R. Carroll ◽  
Sergei A. Tjulandin ◽  
Luis Javier Barajas-Figueroa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Open Label ◽  
Double Blind ◽  
Myelosuppressive Chemotherapy ◽  
Subsequent Cycle ◽  
Phase Iii Study ◽  
Chemotherapy Dose

Purpose We evaluated the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia associated with docetaxel in breast cancer patients. Patients and Methods Patients were randomly assigned to either placebo or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day chemotherapy cycle of 100 mg/m2 docetaxel. The primary end point was the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C and neutrophil count < 0.5 × 109/L on the same day of the fever or the day after). Secondary end points were incidence of hospitalizations associated with a diagnosis of febrile neutropenia, intravenous (IV) anti-infectives required for febrile neutropenia, and the ability to maintain planned chemotherapy dose on time. Patients with febrile neutropenia were converted to open-label pegfilgrastim in subsequent cycles. Results Nine hundred twenty-eight patients received placebo (n = 465) or pegfilgrastim (n = 463). Patients receiving pegfilgrastim, compared with patients receiving placebo, had a lower incidence of febrile neutropenia (1% v 17%, respectively; P < .001), febrile neutropenia–related hospitalization (1% v 14%, respectively; P < .001), and use of IV anti-infectives (2% v 10%, respectively; P < .001). The percentage of patients receiving the planned dose on time was similar between patients receiving pegfilgrastim and patients who initially received placebo (80% and 78%, respectively), as would be expected of the study design. Pegfilgrastim was generally well tolerated and safe, and the adverse events reported were typical of this patient population. Conclusion First and subsequent cycle use of pegfilgrastim with a moderately myelosuppressive chemotherapy regimen markedly reduced febrile neutropenia, febrile neutropenia–related hospitalizations, and IV anti-infective use.

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